The Covid-19 pandemic has emerged as an unprecedented global challenge. Total global cases exceed 13 million with almost 600 000 deaths, and economies are in crisis around the globe. Even as the pandemic continues to spread, the world is still learning more about this virus, with the World Health Organization (WHO), on July 7 2020 acknowledging “evidence is emerging” of the airborne spread of the novel coronavirus.
The pandemic has caused a public health crisis of world-wide proportions and crippled the global economy. The International Monetary Fund (IMF) projects that more than 170 countries will experience negative per capita income growth this year, and that the resulting loss in world economic output in 2020-2021 will be $9 trillion — a bleak outlook that applies to advanced and developing economies alike. As the world goes through this pandemic, there has been a lot of panic and several products have been purported as remedies, with markets being flooded with falsified and unauthorised medicines.
It is important that people, always, are able to access good quality and safe medicines. Disparities in health outcomes around the world are emblematic of unequal access to health care. In Africa, lack of harmonised regulatory processes is a critical barrier to timely access to essential medicines. Different regulatory processes result in delays for researchers and manufacturers, who must navigate multiple regulatory systems to register the same health product across multiple countries.
The availability of safe, good quality and affordable medicines and other health products remains a challenge for many African countries. Some of the contributing factors
, include non-existent, inadequate or outdated legal frameworks and limited capacity.
The treaty for establishing the African Medicines Agency (AMA) was adopted by African heads of state in February 2019 with the main objective of enhancing the capacity of state authorities and Regional Economic Communities (RECs), to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent. Increased collaboration — such as through streamlining regulatory requirements, guidelines and standards; pooling resources and expertise; sharing information and proving technical assistance; often referred to as regulatory harmonization — has a real impact and can accelerate the timeline for review of new products by 40-60%. While it often takes years for a new product to be registered, an accelerated timeline could mean life or death for patients waiting on lifesaving medical products.
The Covid-19 pandemic has amplified the urgent need for countries and the African continent to invest in strong medicines and medical products regulatory frameworks. Although African countries have National Medicines Regulatory Authorities (NMRA’s) which are responsible for regulating, investigating, inspecting, registering, and controlling medicines, clinical trials, medical devices and related matters, the capabilities of these NMRA’s is at different levels and they face challenges in the delivery of quality, safe and effective medical product to the people that need them the most.
Even as the world goes through the Covid-19 pandemic, strengthening and streamlining the medicines regulations processes within the region will limit and alleviate the challenges faced by NMRA’s, consequently leading to increased access to effective medical products. It will also ensure that medical products and devices that are provided are safe and of good quality.
As research and development in response to Covid-19 continues to grow, the role of enhanced collaboration by national medicines regulatory authorities in the region becomes even more important. If AMA is ratified by countries, it will allow for:
- Sharing of information, such as inspection findings between regulatory authorities;
- Aligning safety and efficacy standards and processes used to assess and monitor research and products;
- Conducting joint reviews of research protocols and product dossiers and inspections of research and manufacturing sites; and
- Mutual recognition of assessments and inspections conducted, and decisions made by other regulatory authorities.
Regulatory harmonisation will also mean that under-resourced NMRA’s can benefit from expertise of other authorities in the region, especially in the field of clinical studies for vaccine development and the use of approved medicines for treatment to allow increased access to life-saving medicine. Regions that have more harmonised efforts such as the European Union’s European Medicines Agency (EMA) have advocated for a joint effort in clinical trials for a vaccine. As the African Union works towards the ratification and establishment of the African Medicines Agency, Covid-19 has reminded us of the need for increased local capacity in medical products regulations.
Furthermore, AMA will help ensure that medicines and medical products that are approved in one region of the continent can be approved in expedited time in other regions in the continent, especially in a time of a pandemic. The decrease in the amount of time to register medicines has shown to significantly increase lives saved and expand access to essential health technologies. It also improves quality assurance, accelerate approval processes, clarifies approval pathways and reduces cost.
The Covid-19 crisis has made it clear that African countries must work together to solve this crisis, and the AMA offers one solution to ensuring Africans across the continent have access to lifesaving innovations as they are developed. Countries need to sign and ratify the AMA treaty if access to medicines and medical devices is to be improved in the continent. — Margareth Ndomondo-Sigonda – AUDA-NEPAD Head of Health